Device Recall MicroStream Filterline ICU

  • Modelo / Serial
    Lot Numbers: M8286M10 M8300M10 M8544B11
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    MicroStream Filterline Infant/Neonatal products: Part # 008598 - FILTERLINE H SET INF/NEO 25UN DRAEGER(Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. || The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Oridion Medical 1987 Ltd., 7 Hamarpe St., P.O. Box 45025, Har Hotzvim Industrial Park, Jerusalem Israel
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

3 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot Numbers: M8406P10 M8544B11
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    MicroStream Filterline Infant/Neonatal products: Part # 006285 - FILTERLINE H SET INF/NEO 25 UN PHYSIO (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. || The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: M8286M10 M8300M10 M8406P10 M8544B11 M8555B11 M8575B11
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    MicroStream Filterline Infant/Neonatal products: Part # 006324 - FILTERLINE H SET INF/NEO 25 UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. || The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: M8535B11 M8573B11
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    Micro Stream Filterline Infant/Neonatal products: Part # 010807 - VlTALINE H SET INFANT/NEONATAL 25UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. || The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.
  • Manufacturer